MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97714 |
Device Problems
Failure to Interrogate (1332); No Device Output (1435); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The reason for call was pt cannot connect to charge her ins since yesterday (b)(6) 2021 pt thinks her ins is "undercharged" pt stated she did a "trickle charge{ on her own yesterday and today is seeing por on the recharger.Pt stated that afield rep showed her how to do a trickle charge before so she could do it on her own as needed.Pt stated she dislocated her hip a week ago last tuesday so has not been able to charge her ins pt tried to connect with the pt programmer and saw the icon "charge ins." pt tried to put the charger back on and stated the screen is still showing por and pt could not clear the screen.Pss walked pt through a reset of the insr.Pt stated she is connected and charging the ins battery pt stated the first tile is shaded and the second tile is flashing.Pt tried to turn stim on and saw "por" message.Pss suggested that pt continue to charge the ins battery and call back by 4:30pm to clear the por message with the pt programmer.Caller was redirected to the healthcare provider (hcp).
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient and it was reported pt called back about this same issue and is no longer seeing a por code, they are now seeing an eos code.Pt stated that they had to do a trick charge, as reported in original call.They provided an additional piece of this issue which was a dislocated their right hip 3 weeks ago, and then after that was when the charging issues started.I redirected to hcp.
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Event Description
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The patient will be having the implantable neurostimulator replaced; however, they are looking for a surgeon who is closer to them.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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